REACH What is REACH? European Union regulation concerning R - PowerPoint PPT Presentation

REACH

What is REACH? • European Union regulation concerning R egistration, E valuation, A uthorisation and restriction of Ch emicals • Aims: – To provide a high level of protection of human health and the environment from the use of chemicals – To make manufacturers and importers who place chemicals on the market responsible for understanding and managing the risks associated with their use – To allow the free movement of chemicals on the EU market – To enhance innovation in and the competitiveness of the EU chemicals industry – To promote the use of alternative methods for the assessment of the hazardous properties of substances and read across of data

REACH Requirements • REACH applies to substances manufactured or imported into the EU in quantities of 1 tonne per year or more • REACH requires manufacturers and importers of substances to register them with the European Chemicals Agency (ECHA) • It is illegal to manufacture or supply substances that have not been registered (unless substance exemptions apply)

REACH Requirements • Registration takes place by means of a registration dossier which must be provided to ECHA • Manufacturers and importers must collect and collate specified sets of information on properties of substances they manufacture or supply at or above 1 tonne per year • REACH will ensure very high risk substances are adequately controlled and progressively substituted by safer substances/technologies or only used where there is an overall benefit for society

General Registration Dossier • General Registrant Information • Substance Identification • Substance Manufacture & Use • Classification & Labelling • Guidance on Safe Use Concerning • Exposure Information • Physiochemical Properties • Toxicological Information • Ecotoxicological Information • Methods of Detection And Analysis

REACH Requirements • Manufactures and importers must provide downstream users with the risk information needed to use the substance safely • This is done via classification and labelling and Safety Data Sheets (SDS) where needed

Information required in SDS 1. Substance & Company Identification 2. Hazards Identification 3. Compositional Information 4. First Aid Measures 5. Fire Fighting Measures 6. Accidental Release Measures 7. Handling & Storage Information 8. Exposure Controls/Personal Protection 9. Physical & Chemical Properties 10. Stability & Reactivity 11. Toxicological Information 12. Ecological Information 13. Disposal Considerations 14. Transport Information 15. Regulatory Information 16. Other Information

REACH Requirements • The following materials are exempted from REACH: – Specific substances listed under Annex IV of Regulation (see: http://www.reach- compliance.eu/english/legislation/reach-exemptions.html) – Substances covered by Annex V (includes substances which occur in nature, if they are not chemically modified, including natural gas, LPG, crude oil) – Monomers bound into polymers (but registration required if monomer present at ≥ 2% w/w in the polymer and is at ≥ 1 tonne per annum) – Polymers – Food & food ingredients – Waste and certain recycled materials – Substances needed in the interests of defence • Petroleum substances (except sulphur) are recognised by REACH as substances of “Unknown or Variable composition, Complex reaction products or Biological materials” (“UVCBs”) • Petroleum products and blendstocks imported in quantities in excess of 1 tonne per annum are generally not exempted and will all need to be registered – Concawe have undertaken a programme of risk assessment of petroleum substances, including development of risk assessment methodologies to which members have access – see link at end of talk

REACH Implementation Timeline DATE TARGET 01/06/07 REACH comes into force 01/06/08 ECHA becomes operational 01/06/08 to Pre-registration period (during which substances already being manufactured and supplied (“Phase - in” substances) are “pre - registered” (without a full registration dossier) 30/11/08 to give extended registration deadlines) 01/12/08 Registration for existing substances (that have not been pre-registered) begins 01/01/09 List of pre-registered substances published and Substance Information Exchange Forum (SIEF) formed Phase 1 – Deadline for registration for pre- registered “phase - in” substances supplied at 01/12/10 greater than or equal to 1000 tonnes per annum (also ≥ 100 tonnes/annum if classed under CHIP* as very toxic to aquatic organisms and ≥ 1 tonne/annum if classed under CHIP* as Cat 1 or Cat 2 carcinogens, mutagens or reproductive toxicants) Phase 2 – Deadline for registration of substances supplied at greater than or equal to 01/06/13 100 tonnes per annum Phase 3 – Deadline for registration of substances supplied at greater than or equal to 1 01/06/18 tonne per annum *CHIP = Chemical Hazard Information and Packaging for Supply regulations

MTD REACH Services • Education – Training on nature of different commodities, production processes, additives – Significance of chemical & physical testing • Testing Services – Full product survey – Compositional Testing for Registration Dossier – Physiochemical Testing • Company Product Survey – Identification of all products and other materials (e.g. Additives) shipped at quantities > 1 tonne per annum – Production of reference specifications – Guidelines for independent inspectors • Safety Data Sheet Preparation – Compositional data – Handling & Storage Information – Exposure Controls/Personal Protection – Physical & Chemical Properties

Useful Links • European Chemicals Agency Website: http://echa.europa.eu/ • EU REACH Document: http://www.hse.gov.uk/REACH/resources/regulation.pdf • Concawe: http://www.concawe.be/Content/Default.asp (Oil Companies’ European Association for Environment, Health & Safety in Refining & Distribution)